MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II; COUNTER, DIFFERENTIAL CELL

Catalog Number	338962
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error messages were bypassed and testing continued during use with the bd facscanto¿ ii.The following information was provided by the initial reporter: mdr safety checklist - error messages (case) 1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes.2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes.3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required.): yes.4.Is this presto? no.It was reported by the customer that fluidic board requesting shutdown - float switch timeout during a long clean.Fluidic board requesting shutdown - float switch timeout during a long clean.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.E.1.Initial reporter address 1: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Could you please verify - error message was observed by the user during long clean of the instrument.Did the customer bypassed the error message and tested patient sample? "yes, error during long clean.But otherwise the instrument was still used for samples as normal.Long clean did not prevent other normal operation of the instrument." user was not testing patient sample during long clean process.It was reported that error messages were bypassed and testing continued during use with the bd facscanto¿ ii.The following information was provided by the initial reporter: mdr safety checklist - error messages (case) 1.Are you running patient samples for diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required.): yes 2.Was there an error message? (if yes, go to question #3.If no, no further questions required.): yes 3.Did the customer bypass the error message? (if yes, go to question #4.If no, no further questions required.): yes 4.Is this presto? no it was reported by the customer that fluidic board requesting shutdown - float switch timeout during a long clean.Fluidic board requesting shutdown - float switch timeout during a long clean.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2023-00193 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.

• Brand Name: BD FACSCANTO¿ II
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17906536
• Report Number: 2916837-2023-00193
• Device Sequence Number: 15365000
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 338962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown